Application 074476

Type: ANDA
Sponsor: ROXANE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROXYUREA	HYDROXYUREA	CAPSULE;ORAL	500MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074476-001	HYDROXYUREA	HYDROXYUREA	500MG	CAPSULE / ORAL			1995-08-18

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A074476-001	HYDROXYUREA	500MG	CAPSULE / ORAL	1995-08-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074476-001	HYDROXYUREA	500MG	CAPSULE / ORAL	1995-08-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074476-001	HYDROXYUREA	500MG	CAPSULE / ORAL	1995-08-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074476-001	HYDROXYUREA	500MG	CAPSULE / ORAL	1995-08-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074476-001	HYDROXYUREA	500MG	CAPSULE / ORAL	1995-08-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074476-001	HYDROXYUREA	500MG	CAPSULE / ORAL	1995-08-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074476-001	HYDROXYUREA	500MG	CAPSULE / ORAL	1995-08-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074476-001	HYDROXYUREA	500MG	CAPSULE / ORAL	1995-08-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074476-001	HYDROXYUREA	500MG	CAPSULE / ORAL	1995-08-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074476-001	HYDROXYUREA	500MG	CAPSULE / ORAL	1995-08-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074476-001	HYDROXYUREA	500MG	CAPSULE / ORAL	1995-08-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074476-001	HYDROXYUREA	500MG	CAPSULE / ORAL	1995-08-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074476-001	HYDROXYUREA	500MG	CAPSULE / ORAL	1995-08-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074476-001	HYDROXYUREA	500MG	CAPSULE / ORAL	1995-08-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074476-001	HYDROXYUREA	500MG	CAPSULE / ORAL	1995-08-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074476-001	HYDROXYUREA	500MG	CAPSULE / ORAL	1995-08-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074476-001	HYDROXYUREA	500MG	CAPSULE / ORAL	1995-08-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074476-001	HYDROXYUREA	500MG	CAPSULE / ORAL	1995-08-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074476-001	HYDROXYUREA	500MG	CAPSULE / ORAL	1995-08-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074476-001	HYDROXYUREA	500MG	CAPSULE / ORAL	1995-08-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074476-001	HYDROXYUREA	500MG	CAPSULE / ORAL	1995-08-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074476-001	HYDROXYUREA	500MG	CAPSULE / ORAL	1995-08-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074476-001	HYDROXYUREA	500MG	CAPSULE / ORAL	1995-08-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074476-001	HYDROXYUREA	500MG	CAPSULE / ORAL	1995-08-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074476-001	HYDROXYUREA	500MG	CAPSULE / ORAL	1995-08-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074476-001	HYDROXYUREA	500MG	CAPSULE / ORAL	1995-08-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074476-001	HYDROXYUREA	500MG	CAPSULE / ORAL	1995-08-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074476-001	HYDROXYUREA	500MG	CAPSULE / ORAL	1995-08-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074476-001	HYDROXYUREA	500MG	CAPSULE / ORAL	1995-08-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074476-001	HYDROXYUREA	500MG	CAPSULE / ORAL	1995-08-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074476-001	HYDROXYUREA	500MG	CAPSULE / ORAL	1995-08-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074476-001	HYDROXYUREA	500MG	CAPSULE / ORAL	1995-08-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074476-001	HYDROXYUREA	500MG	CAPSULE / ORAL	1995-08-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074476-001	HYDROXYUREA	500MG	CAPSULE / ORAL	1995-08-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074476-001	HYDROXYUREA	500MG	CAPSULE / ORAL	1995-08-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074476-001	HYDROXYUREA	500MG	CAPSULE / ORAL	1995-08-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074476-001	HYDROXYUREA	500MG	CAPSULE / ORAL	1995-08-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074476-001	HYDROXYUREA	500MG	CAPSULE / ORAL	1995-08-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074476-001	HYDROXYUREA	500MG	CAPSULE / ORAL	1995-08-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074476-001	HYDROXYUREA	500MG	CAPSULE / ORAL	1995-08-18	`f41ea6bd6efb…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydroxyurea	HYDROXYUREA	Major Pharmaceuticals	e76fd60e-7644-48c5-9857-3608a045000b	2026-05-27	Warnings, Adverse reactions	Name fallback brand name: Hydroxyurea generic name: HYDROXYUREA
Hydroxyurea	HYDROXYUREA	Par Health USA, LLC	9e1bdd4b-043a-4cf6-b1ff-8de49e02b7a6	2026-05-07	Warnings, Adverse reactions	Name fallback brand name: Hydroxyurea generic name: HYDROXYUREA
Hydroxyurea	HYDROXYUREA	American Health Packaging	c84a2241-6c05-480f-8a5b-049e08c27d73	2026-03-02	Warnings, Adverse reactions	Name fallback brand name: Hydroxyurea generic name: HYDROXYUREA
XROMI	HYDROXYUREA	Nova Laboratories, Ltd.	4b37d336-86da-4363-aef1-34a7d3ba973b	2026-02-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: HYDROXYUREA
HYDREA	HYDROXYUREA	H2-Pharma LLC	6053c775-68de-45e4-9af9-33b18fd0e140	2026-01-26	Warnings, Adverse reactions	Name fallback generic name: HYDROXYUREA
DROXIA	HYDROXYUREA	H2-Pharma LLC	a9494409-3571-4a81-9ad3-15ef7cb636a2	2026-01-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: HYDROXYUREA
Siklos	HYDROXYUREA	Medunik	76957c0d-0f98-4376-bb06-eee651adc09d	2026-01-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: HYDROXYUREA
HYDROXYUREA	HYDROXYUREA	Coupler LLC	44fd5379-5fb0-ff62-e063-6294a90ac792	2025-12-02	Warnings, Adverse reactions	Name fallback brand name: HYDROXYUREA generic name: HYDROXYUREA
HYDROXYUREA	HYDROXYUREA	AvKARE	862583ff-6d5c-3f7d-e3bd-352fb0400928	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: HYDROXYUREA generic name: HYDROXYUREA
HYDREA	HYDROXYUREA	Waylis Therapeutics LLC	8d41152f-a98a-4abc-afdf-a909012434a0	2025-09-15	Warnings, Adverse reactions	Name fallback generic name: HYDROXYUREA
DROXIA	HYDROXYUREA	Waylis Therapeutics LLC	4ad13dc6-a2ab-4308-96b3-7c642c92cc23	2025-09-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: HYDROXYUREA
HYDROXYUREA	HYDROXYUREA	Golden State Medical Supply, Inc.	1b42f2b4-3880-e7a9-e063-6294a90a5fd0	2024-11-25	Warnings, Adverse reactions	Name fallback brand name: HYDROXYUREA generic name: HYDROXYUREA
HYDROXYUREA	HYDROXYUREA	Leading Pharma, LLC	4c4e1c2f-2143-44f3-8825-aeba42e755e4	2024-10-29	Warnings, Adverse reactions	Name fallback brand name: HYDROXYUREA generic name: HYDROXYUREA
HYDROXYUREA	HYDROXYUREA	Somerset Therapeutics, LLC	9752a347-b42c-44d5-8fd1-c538f7f239dc	2024-09-23	Warnings, Adverse reactions	Name fallback brand name: HYDROXYUREA generic name: HYDROXYUREA
HYDROXYUREA	HYDROXYUREA	Teva Pharmaceuticals USA, Inc.	b9514ae5-79ae-4cc2-9d7f-c8f7806d1694	2024-05-30	Warnings, Adverse reactions	Name fallback brand name: HYDROXYUREA generic name: HYDROXYUREA
HYDROXYUREA	HYDROXYUREA	Qilu Pharmaceutical Co., Ltd.	4cd244d4-bd4a-41c8-b072-c2135787d412	2024-04-30	Warnings, Adverse reactions	Name fallback brand name: HYDROXYUREA generic name: HYDROXYUREA

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.